苯妥英钠和丙戊酸钠预防术后癫痫的对照研究

Phenytoin or sodium valproate for prophylaxis of postoperative epilepsy: A randomised comparison.

目的 对比苯妥英钠和丙戊酸钠预防术后癫痫的作用、毒副反应以及和血药浓度的关系。方法 采用随机前瞻对照性研究 ,选择幕上开颅手术病人 ,苯妥英纳组 72例 ,丙戊酸钠组 80例 ,术前术后分别规则服用苯妥英钠和丙戊酸钠 ,监测抗癫痫药物的血药浓度和术后癫痫及毒副反应发生情况。结果 两组共 15例术后发生早期癫痫 ,10例 (10 /15 )达到有效血浓度 ;其中 ,苯妥英钠组 6例 (8 3 % )发生早期癫痫 ,2例达到有效血浓度 ,丙戊酸钠组 9例 (11 3 % )发生早期癫痫 ,8例达到有效血浓度 ;远期癫痫发作 7例中丙戊酸钠组 5例 ,苯妥英钠组 2例。苯妥英钠组 11例 (15 3 % )及丙戊酸钠组2例 (2 5 % )出现了毒副反应。经χ2 检验 ,两组术后癫痫发生率无显著性差异 ,术后未发癫痫组和癫痫发作组间药物血浓度无显著性差异 (P >0 0 5 ) ,苯妥英钠组毒副反应发生率高于丙戊酸钠组。结论 苯妥英钠和丙戊酸钠预防控制术后癫痫无差别 ,苯妥英钠毒副反应较丙戊酸钠严重。

Objective To compare the efficacy and tolerability of phenytoin and valproate for prophylaxis of postoperative epilepsy. Methods A randomised prospective study was performed. There were 72 patients in the group of phenytoin and 80 patients in the group of valproate. The pattern of seizures and serum anticonvulsant levels were monitored in all patients. Results Fifteen of 152 patients suffered from seizures in the first week after operation: 6 patients in the group of phenytoin and 9 patients in the group of valproate. Optimal serum anticonvulsant levels were achicved in 111 patients. Ten patients had early postoperative seizures and 101 patients did not. Eleven patients suffered from severe side effects in the group of phenytoin and only two patients had minor side effects in the group of valproate. Conclusions There was no significant difference between these two groups regarding of the efficacy to prevent early post operative seizures. Our data did not suggested that those patients who had sub optimal serum level would more likely to have seizures than those who did. Serious complications were significantly more frequent in the phenytoin group.